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Sodium 4-aminosalicylate dihydrate is a stable, water-soluble sodium salt of 4-aminosalicylic acid, critical for treating multidrug-resistant tuberculosis (MDR-TB) and inflammatory bowel diseases. Its dihydrate form offers superior resistance to oxidation and discoloration compared to anhydrous variants, ensuring extended shelf life and consistent potency. Key selling points include exceptional purity with tightly controlled impurities (e.g., 3-amino isomer), meeting strict USP/EP pharmacopoeial standards for global regulatory approval. We provide comprehensive DMF support, full traceability, and GMP-certified scalable production from grams to metric tons. Ideal for generic manufacturers and global health programs, its high solubility facilitates diverse formulations like oral granules and IV solutions. Sold strictly as a pharmaceutical raw material for legal manufacturing use only; not for direct human consumption without further processing.
Items | Specifications | Results |
Appearance | Off-white or slightly yellowish powder | Conforms |
Identification | react positive | Conforms |
The color and clarity of the solution | comply with the regulations | |
M-aminophenol | ≤0.05% | Conforms |
Loss on Drying | 16.0-17.5% | 16.8% |
PH | 6.5-8.5 | 7.41 |
heavy metal content | Conforms | |
ferric salt | ≤15ppm | |
chloride | ≤0.005% | Conforms |
sulfate | ≤0.05% | Conforms |
Content | ≥99.0% | 99.40% |
Conclusion | The product conforms to the above specifications. | |
Sodium 4-aminosalicylate dihydrate (CAS No. 6018-19-5; anhydrous form CAS 133-10-8) is the sodium salt of 4-aminosalicylic acid (PAS), stabilized with two molecules of water.
Chemical Nature: It is a white to off-white crystalline powder, highly soluble in water. The dihydrate form offers enhanced stability compared to the anhydrous salt, preventing rapid oxidation of the sensitive amino group.
Primary Applications:
Anti-Tuberculosis Agent: Historically and currently used as a second-line antibiotic for treating multidrug-resistant tuberculosis (MDR-TB), inhibiting bacterial folate synthesis.
Anti-inflammatory: Used in the treatment of inflammatory bowel diseases (e.g., ulcerative colitis) in some regions.
Pharmaceutical Intermediate: A key starting material for synthesizing related salicylate derivatives and mesalazine impurities.
Key Selling Points
Targeted at pharmaceutical manufacturers, generic drug developers, and research institutions:
Superior Stability (Dihydrate Form):
The dihydrate crystal lattice provides excellent protection against oxidation and discoloration (a common issue with aminosalicylates), ensuring a longer shelf life and consistent potency during storage and transport.
High Purity & Low Impurity Profile:
Manufactured with strict control over critical impurities (e.g., 3-amino isomer, salicylic acid, heavy metals), meeting stringent pharmacopoeial standards (USP, EP, ChP). Essential for passing regulatory audits for MDR-TB drug formulations.
Regulatory Compliance & Documentation:
Supplied with comprehensive DMF (Drug Master File) support, Certificates of Analysis (COA), and full traceability. Ideal for companies filing ANDAs or seeking WHO prequalification for tuberculosis treatments.
Optimized Solubility for Formulation:
The sodium salt form offers high aqueous solubility, facilitating the development of various dosage forms including oral granules, tablets, and even intravenous solutions required for severe TB cases.
Scalable GMP Production:
Produced in GMP-certified facilities with capacity for metric-ton scale supply, ensuring reliable sourcing for global health programs and large-scale generic manufacturing.
Important Notice: This product is sold strictly as a pharmaceutical raw material or research chemical for legal manufacturing and laboratory use. It is not a finished dosage form for direct human consumption without further processing and regulatory approval.



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